Front Line Agreement in Diagnosis and Treatment for Musculoskeletal Dysfunctions

NCT07443098 | Completed DMC

• 2 other identifiers: Bern UniversityApplied Science2023-01399
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Background: This randomized study, conducted from October to December 2023 in the emergency department of Bethesda Hospital Basel, Switzerland, investigated a new model of care for patients presenting with non-urgent musculoskeletal disorders (MSKDs). It was initiated in response to two major challenges in the Swiss healthcare system: a shortage of general practitioners and a rising number of ED visits for conditions such as back, neck, and shoulder pain, sprains, and other joint or muscle complaints without serious underlying pathology. Internationally, Advanced Physiotherapy Practice (APP) roles, in which specially trained physiotherapists independently assess, diagnose, treat, and discharge patients with appropriate MSKDs, have been successfully implemented in emergency settings, but this model is still novel in Switzerland, and local evidence on safety and comparability to medical care is lacking. Methods: A total of 102 patients with musculoskeletal complaints and no signs of serious structural or systemic disease were included after informed consent. Patients were randomly assigned either to an intervention group, managed by physiotherapists working in an advanced practice role, or to a control group receiving standard care from resident physicians. Senior physicians, acting as reference standard, reviewed clinical findings, diagnoses, treatment recommendations, and discharge decisions from both groups. Agreement between each provider group and senior physicians was quantified using established measures of inter-rater reliability, specifically Cohen's Kappa (κ) and Gwet's AC1, to determine concordance beyond chance. Conclusions: This study aims to determine whether advanced practice physiotherapists can provide clinical decision-making comparable to resident physicians for non-urgent MSKDs in the ED. Demonstrating high levels of agreement in diagnosis, management, and discharge planning would support the safe integration of APP roles into Swiss emergency workflows, with potential benefits including reduced waiting times, more efficient use of physician resources, improved patient flow, and maintenance of high standards of care and patient safety, thereby informing workforce planning and task-sharing strategies in acute care.

Conditions

Musculoskeletal Diseases; Low Back Pain; Emergency Service, Hospital; Physical Therapy Modalities; Diagnostic Techniques and Procedures; Clinical Competence; Patient Discharge

Keywords

Diagnostic & management; emergency department; musculoskeletal disorders; advanced practice physiotherapy; RCT

Outcome Measures

Primary Outcomes (2)

• Agreement

  Description:The primary outcome will be the level of agreement, measured using Cohen's Kappa (κ) and Gwet's AC1 (AC1), regarding diagnosis and follow-up recommendations between ED-PTs resp. residents (control group), and the senior physician.

  From enrollment to the end of treatment at 13 weeks.

• Diagnostic Competence APP

  Cohen's Kappa (κ) and Gwet's AC1 (AC1) with 95% confidence interval (CI) for the review of the diagnosis and follow-up recommendations

  From enrollment to the end of treatment at 13 weeks

Study Arms (2)

Intervention Arm (Advanced Practice Physiotherapist-Led Care)

EXPERIMENTAL

All patients in the ED-PT groups (3 subgroups) will undergo a medical history assessment and standardized red flag screening (Boissonnault, 2011; Lüdtke, 2021) to exclude non-musculoskeletal causes. The questionnaire will be signed by both the patient and the ED-PT. Patients with identified red flags will be excluded before randomization. Additionally, all cases will be reviewed by a senior physician to ensure safety. After exclusion of red flags, the ED-PT will perform the clinical assessment, establish a provisional diagnosis, and develop a management and discharge plan. All data will be recorded in a CRF. Before discharge, a senior physician will review and confirm the plan (yes/no) and retain final medical responsibility. A written report to the GP will conclude the ED consultation.

Diagnostic Test: Intervention: ED - physiotherapist group

Experimental: Control Arm (Resident physician-Led Care)

ACTIVE COMPARATOR

Resident physicians (RPs) will perform the initial clinical assessment and propose a diagnosis and management plan, which will be reviewed and approved by a senior physician prior to discharge, in accordance with standard emergency department procedures at Bethesda Hospital AG (BSAG). The same predefined clinical workflow will be applied in both groups (RP and ED-PT).

Diagnostic Test: Control: resident physician group

Interventions

Intervention: ED - physiotherapist group DIAGNOSTIC_TEST

All patients in the ED-PT groups (3 subgroups) will undergo a medical history assessment and standardized red flag screening (Boissonnault, 2011; Lüdtke, 2021) to exclude non-musculoskeletal causes. The questionnaire will be signed by both the patient and the ED-PT. Patients with identified red flags will be excluded before randomization. Additionally, all cases will be reviewed by a senior physician to ensure safety. After exclusion of red flags, the ED-PT will perform the clinical assessment, establish a provisional diagnosis, and develop a management and discharge plan. All data will be recorded in a case report form (CRF). Before discharge, a senior physician will review and confirm the plan (yes/no) and retain final medical responsibility. A written report to the GP will conclude the ED consultation.

Intervention Arm (Advanced Practice Physiotherapist-Led Care)

Control: resident physician group DIAGNOSTIC_TEST

Resident physicians (RPs) will perform the initial clinical assessment and propose a diagnosis and management plan, which will be reviewed and approved by a senior physician prior to discharge, in accordance with standard emergency department procedures at Bethesda Hospital AG (BSAG). The same predefined clinical workflow will be applied in both groups (RP and ED-PT).

Experimental: Control Arm (Resident physician-Led Care)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 79 years presenting with non-serious musculoskeletal conditions
• report a pain intensity between 3 and 7 on a 0-10 Numeric Rating Scale (NRS).

You may not qualify if:

• major trauma, fracture
• systemic signs (e.g., fever or unexplained profuse sweating)
• progressive neurological deficits (i.e., severe sensory loss or weakness)
• cauda equina syndrome with bladder or bowel dysfunction
• progressive deterioration of the general condition
• severe acute medical distress (e.g., suspected myocardial infarction)
• allergic reaction with or without skin rashes
• acute mental illness (psychological condition)
• Patients who are unwilling or unable to provide informed consent or lacking decision-making capacity.

Sponsors & Collaborators

• Bern University of Applied Sciences: lead

Study Sites (1)

Bethesda Spital AG - Basel

Basel, 4052, Switzerland

Location

Related Publications (6)

• Winteler, B., Geese, F., Lehmann, B., & Schmitt, K.-U. (2022). Musculoskeletal Physiotherapy in the Emergency Department - Evaluation of a New Physiotherapy Service in a Swiss University Hospital. Physioscience, 18(02), 69-76. https://doi.org/10.1055/a-1500-1077

  BACKGROUND

• Goodwin, R. W., & Hendrick, P. A. (2016). Physiotherapy as a first point of contact in general prac-tice: A solution to a growing problem? Primary Health Care Research & Development, 17(5), 489-502. https://doi.org/10.1017/S1463423616000189

  BACKGROUND

• Ferreira, G. E., Traeger, A. C., & Maher, C. G. (2019). Review article: A scoping review of physiother-apists in the adult emergency department. Emergency Medicine Australasia, 31(1), 43-57. https://doi.org/10.1111/1742-6723.12987

  BACKGROUND

• Downie, F., McRitchie, C., Monteith, W., & Turner, H. (2019). Physiotherapist as an alternative to a GP for musculoskeletal conditions: A 2-year service evaluation of UK primary care data. Brit-ish Journal of General Practice, 69(682), e314-e320. https://doi.org/10.3399/bjgp19X702245

  BACKGROUND

• de Gruchy, A., Granger, C., & Gorelik, A. (2015). Physical Therapists as Primary Practitioners in the Emergency Department: Six-Month Prospective Practice Analysis. Physical Therapy, 95(9), 1207-1216. https://doi.org/10.2522/ptj.20130552

  BACKGROUND

• Bird, S., Thompson, C., & Williams, K. E. (2016). Primary contact physiotherapy services re-duce waiting and treatment times for patients presenting with musculoskeletal conditions in Australian emergency departments: An observational study. Journal of Physiotherapy, 62(4), 209-214. https://doi.org/10.1016/j.jphys.2016.08.005

  BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases; Low Back Pain; Emergencies; Disease

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Amir Tal, PhD

  Bern University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding will not be feasible due to the nature of the intervention, as the presence of both the physiotherapist or resident physician and the senior physician will be required during the assessment to ensure accurate implementation and interpretation.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Amit Tal

Model Details: This study will use a prospective, randomized, controlled, single-center interventional design conducted in the emergency department of Bethesda Hospital Basel. Eligible adult patients presenting with non-urgent musculoskeletal conditions will be randomly assigned to either assessment and management by an Advanced Practice Physiotherapist (intervention group) or standard care by a resident physician (control group). Randomization will be performed using concealed allocation with sealed envelopes. In both groups, diagnoses, treatment recommendations, and discharge decisions will be reviewed by a senior physician, who will serve as the reference standard. The study will compare agreement in clinical decision-making between groups to evaluate the safety and competence of advanced physiotherapy practice in the emergency department setting.

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 2, 2026
• Study Start: October 3, 2023
• Primary Completion: December 23, 2023
• Study Completion: January 31, 2024
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)